Shingrix: side effects, ingredients & package insert

Shingrix ingredients (FDA package insert, Section 11)

Per-dose composition as stated in the prescribing information; verified 2026-07-09. Click an ingredient for every vaccine that contains it.

Source: FDA package insert. Formulations change — re-verify before clinical use.

Shingrix side effects: where the data is

Reported reactions for Shingrix and the other shingles (zoster) products are compiled on the shingles (zoster) vaccine page: pre-licensure trial reactogenicity, VAERS report counts, and international databases (Canada Vigilance, EudraVigilance, Lareb, VigiAccess). Those counts are spontaneous reports with no denominator — a report does not establish that the vaccine caused the event.

• Pre-licensure clinical trial data
• Post-licensure surveillance (VAERS and international)
• Documented adverse events and causality assessment
• Vaccine Injury Table (VICP) — compensable injuries

Shingrix lot number lookup

Schedule and age range

Licensed ages and the recommended series for shingles (zoster) vaccines are on the shingles (zoster) vaccine page; how 31 countries schedule it is on shingles (zoster) schedule by country. Always confirm the product-specific age range in the current package insert.

Common questions about Shingrix

What are the side effects of Shingrix?

Common reactions listed in the Shingrix package insert are injection-site pain, redness or swelling and short-lived systemic symptoms such as fever, tiredness or irritability. Rarer events and the reported counts from VAERS and international databases are on the shingles (zoster) vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Shingrix?

Shingrix contains Recombinant varicella-zoster virus glycoprotein E (gE) as antigen; adjuvant: AS01B; it is preservative-free. Excipients: Sucrose, Polysorbate 80, Sodium dihydrogen phosphate dihydrate / dipotassium phosphate, Sodium chloride. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Shingrix package insert?

The FDA-licensed prescribing information for Shingrix is published by GlaxoSmithKline Biologicals and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/shingrix. Formulations change, so re-verify the current insert before clinical use.